JP5588554B2 - 心臓活動を正確に分類するための装置 - Google Patents
心臓活動を正確に分類するための装置 Download PDFInfo
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Description
以下の例と説明の幾つかにおいては、登録特許と係属特許出願が参照される。これらの参考文献は説明を目的としており、本発明をこれらの参照される特許および特許出願の特定の方法または構造体に制限することを意図しない。
を示す。図16は、算出された鼓動の速さを複数の過検出識別方法14,16,18の選択に使用する一例を示す。
評価は、有意なノイズがある検出イベントを疑性(suspect)イベントとして標識することができる。たとえば所定期間、信号が零を跨ぐ数または信号の第1導関数もしくは第2導関数が零を跨ぐ数をカウントすることによって、ノイズは識別されてもよい。「心臓波形評価を行うための方法および装置(METHOD AND DEVICES FOR PERFORMING CARDIAC WAVEFORM APPRAISAL」と題する米国特許第7,248,921号明細書は、波形評価34についての追加の詳細例を提供する。
含んでもよい。
AN IMPLANTABLE CARDIOVERTER−DEFIBRILLATOR)」と題する米国特許出願公開第2006/0167503号明細書は、これらの概念の例示的な幾つかの例を提供する。
電極が、システム全体にわたって複数の位置に配置される。電極64,68,70,72は任意の適切な形式をとってもよく、任意の適切な材料で作ることができる。たとえばキャニスタ電極64は分離したボタン電極であってもよく、またはキャニスタ62の一領域または一表面であってもよく、リード66上の電極68,70,72はコイル電極、リング電極、または本技術において知られる他の構造体であってもよい。
は次に限定されないが、腋窩、胸筋、および胸筋下の位置を含む、前部、側部、および後部の位置に配置されてよく、埋込対象者の胴部の左右または腹部に配置されてもよい。全体としてシステムの血管内埋込についても提案されている。リード66は、前方−後方の組み合わせ、前方のみの組み合わせ、経静脈の場所、または他の血管の場所を含む幾つもの適切な構成に置かれてもよい。
本発明の幾つかの実施形態は、過検出の識別および補正を行うための方法例を提供する。図6A〜図6B、図7A〜図7B、および図8は、相関性を用いて過検出を識別する形態に基づくアプローチを表す。説明の目的で、これらの方法は図5に示す過検出に適用される。
って三重検出が識別されてもよく、更に別の例においては、記憶された静的な形態テンプレートではなく、一連の検出を互いに比較し、新しい検出のそれぞれを別個のテンプレートにしてもよい。更に別の例は、時間の経過とともに変化する動的なテンプレートを使用し、たとえば新しい検出をこのテンプレートに統合することによって、または事前に検出した複数のイベントを平均化することによって使用する。
AND APPARATUS FOR BEAT ALIGNMENT AND COMPARISON)」と題する米国特許第7,477,935号明細書に記載されている。
、図6Bの過検出は記憶されたテンプレートとの低い相関性を表す。図7A〜図7Bと図8は、図5に示す過検出の特性が、いかに過検出を識別するのに使用され得るかを示す。
(A)192に示すように、交互パターン190が求められること、および、
(B)194に示すように、N−3検出のスコアが「高」く、且つ図8のヒステリシスゾーン186より上である必要があること、
の2つの部分がある。イベントが標識される手法から分かるように、ルール194は、3つの検出(N−1,N−2,N−3)のいずれにもヒステリシスゾーン186に収まる相関性スコアがないことを効果的に保証する。
図1〜図2に示すように、過検出を識別するための別の例示的な方法は、交互インタバルパターンを識別するのに、イベントのインタバルを使用する。過検出は、検出イベント間のインタバルを解析することによって識別され得ると考えられる。1組の検出イベントの解析がイベント間における長−短インタバルの交互パターンを示す場合、過検出が生じている場合がある。
3ミリ秒の空帯域定数が使用される場合(他の空帯域定数が使用されてもよい)、境界224,226はそれぞれ377ミリ秒と423ミリ秒(142〜159拍bpm)になる。異なる空帯域の規定(たとえば単に±10bpm、または+10ミリ秒、−20ミリ秒などのオフセット)が代わりに使用されてもよい。
本発明の幾つかの実施形態は、幅広QRS群の過検出識別に関する。図11、図12A〜図12D、図13A〜図13B、および図14は、幅広群の過検出識別を示す。幅広群の過検出識別方法は、短いインタバル内に所定の形態的特徴を備えて検出が生じるか否かを観察する。近接度および形態の特徴が識別される場合、幅広群の過検出識別方法は、過検出が生じていると判断する。
304で分かるように、幅広QRSは2度検出される。このパターンは、306,308で再び繰り返される。
は負であり、第2の検出の極性は正であるため、極性ルールは満足される。上記のとおり、検出インタバルルールは満足される。この結果、図12Cに示す検出イベントパターンによって、図12Bに記載する第1と第2のルールの両方が満足される。
なる。心拍数がこの範囲に入るとシステムは範囲外状態を終了し、範囲内、パターンなしの状態404に入る。
後の方のイベントN−1よりも初めの方のイベントN−2は記憶されたテンプレートとの相関性が低くない場合、N−1イベント(イベントb)は偽と標識され、N−2イベント(イベントa)は真と標識される。 次いでこの方法は452で反復され、時間t2においてイベントb,cはそれぞれN−2,N−1として処理され、ルールが再び適用される。ここではイベントbは既に偽として標識されているため、図13Aの368に示すルールに基づき、イベントcは自動的に真として標識される。幅広群の拍数範囲が満たされる場合、真−偽−真のパターンは、パターン発見の状態が有効となっているか否かに依存して、N−2イベント(イベントb)が幅広群の過検出または幅広群疑性として標識される。この方法は次に454で反復される。
図16には、複数の過検出解析方法の実装について図示する。例示的な例470において、テンプレートを解析に使用されるように確立できる場合、形態過検出解析474と同様に、波形評価472は任意の検出イベント拍数で有効にされてもよい。
願日とし、「埋込型心臓刺激装置における正確な心イベント検出(ACCURATE CARDIAC EVENT DETECTION IN AN IMPLANTABLE
CARDIAC STIMULUS DEVICE)」と題する米国特許仮出願第61/034,938号明細書に示すもののうちの1つと同様である。上記のように、510,512に示す表記「T波の過検出」心周期は、R波と後続のT波の両方が検出につながるため、二重にカウントされている。また、上記の表記「幅広群の過検出」に示すように、このプロファイルはまた、520,522に示すQRS群を二重検出する。検出プロファイルの改良によって、すべての過検出が回避されるとは限らない。
ている以前のインタバルがバッファ650に保持される。たとえばインタバル656のいずれの側の検出も疑性または過検出として標識されない場合、658に示すように解析642が行われると、インタバル656はバッファ650に渡される。
初期化される内部変数で開始する。また開始ブロックは、他の複数のファクタ(たとえば、上記のX/Y条件および持続性条件)が既に満たされると呼び出される。
Total_WC_Beats:バッファ内における幅広群の疑性または幅広群の過検出と標識される検出の数
Max_Cons_01:連続する0〜1のタグの組み合わせの最大数
Max_Cons_02:連続する0〜2のタグの組み合わせの最大数
これらの算出された変数は、次いで図22に示すように使用される。
別できるか否かを判断するために、このような実施形態は真(0)の検出の解析を含んでもよい。
される段階的な解析を含む。検出イベントと静的なテンプレートとの相関性が高い場合、検出イベントは非ショック可能910として標識される。このイベントが静的なテンプレートとの相関性はないが、最近取り込まれた4つのイベントの平均からなる動的なテンプレートとの相関性はよく、幅の狭いQRS群を示す場合にも(この組み合わせは、幅の狭い群を有する単形性の不整脈を示唆する)、この方法は工程910に進む。一方、検出強化912が満足されない場合、914に示すように検出イベントはショック可能として標識される。
[追加の特性]
幾つかの実施形態は、心臓活動監視に関する装置および方法の形式をとる。一例として、埋込型ループレコーダが挙げられる。図1を参照し、監視の実施形態については治療決定22ではなく代わりに、後のアップロードのための特定データを記憶する決定がなされてもよい。たとえば幾つかの埋込型モニタは、異常な活動および/または潜在的に悪性の活動が生じている埋込によって決定がなされるときにのみデータを保持するように構成される。幾つかの更なる実施形態において、長期使用の適性を判断すべくシステムおよび/または埋込位置について感知と検出の特性が解析され得るように、取り込んだデータに補正が必要なとき、データは記憶されてもよい。監視システムはまた、悪性の条件が識別される場合、たとえば埋込対象者への通知によって、または外部警報システムとの通信によって警告を出してもよい。
細書と同様に、持続性のあるファクタが統合されてもよい。持続性のあるファクタは、Y分のXカウンタの要件が、所定数の連続する反復において満たされることを要求する。この例示的な例において、図22の充電確認方法は、持続性のあるファクタに従う追加要件として実装される。つまりこの例示的な例において、所定数の連続する反復においてY分のXカウンタの要件を満たすことによって持続性要件が満たされた後にのみ、充電確認は起動される。非持続性の不整脈条件が識別される場合/とき、持続性のあるファクタおよび/またはX/Yの条件は、米国特許出願公開第2006/0167503号明細書公報に説明されるように修正されてもよい。
上記の説明は、複数の過検出識別方法および関連するデータ補正方法を詳しく述べている。これらの各方法は、幾つかの実施形態において個々に使用されてもよい。たとえば以下に示す幅広群の過検出識別方法は、過検出の識別、および所望により過検出の補正を行
うための独立した方法として使用されてもよい。幾つかの実施形態においては複数の方法が同期して使用される。たとえば形態過検出、交互インタバル、および幅広群の過検出の方法のそれぞれはともに使用されてもよく、個々の検出イベントまたは検出イベント群を続けて解析してもよい。更に他の実施形態において、これらの方法の組み合わせは、所与の条件に応じて使用される。
1.波形評価疑性イベントは、過検出解析に使用できる。任意の方法によって過検出として標識されるイベントは、疑性標識にかかわらず、関連するインタバル補正によって破棄される。
2.任意の方法によって疑性と標識され、任意の方法によって過検出と標識されないイベントは、疑性である。
3.過検出または疑性と標識されないイベントは、過検出または疑性と標識されるのが適格でなくなると認証済みと見なされる。
この例では、波形評価に失敗する検出イベントを、その後の過検出の識別に使用することができる。
1.疑性イベントの波形評価の標識は、該イベントが任意の他の方法によって標識されるのを防ぐ。また、該イベントおよび関連するインタバルは、WA疑性と標識される。
2.WA疑性ではなく過検出と標識されるイベントは、疑性標識にかかわらず、関連するインタバル補正によって破棄される。
3.波形評価以外の任意の方法によって疑性と標識されるイベントは、任意の方法によって過検出と標識されなかった場合、疑性である。
4.過検出または疑性と標識されないイベントは、過検出または疑性と標識されるのが適格でなくなると、認証済みと見なされる。
Claims (6)
- キャニスタに収容された演算回路と、複数の電極の配置されたリード電極アセンブリとを含む埋込型心臓刺激装置(ICSD)において、リード電極アセンブリは、リード電極アセンブリ上の前記電極に前記演算回路を電気的に接続するようキャニスタに接続されるように構成されており、前記演算回路は心臓信号解析の方法を実行するように構成されており、前記方法は、
一連のイベントを検出する工程と、
連続して検出されたイベント間のインタバルを識別する工程と、
前記一連のイベントから過検出を識別するために形態解析を使用する工程と、
過検出が識別されるときには常に、
過検出に先行するインタバルと過検出に続くインタバルとを結合し、結合されたインタバルを形成する工程と、
過検出を識別するための形態解析に続き、結合されたインタバルおよび過検出に隣接していないインタバルを認証する工程と、
認証済みのインタバルのみを使用して、心拍数を推定する工程と、
推定された心拍数を使用して治療決定を行う工程と、を含む、ICSD。 - 前記演算回路は、個々の検出されたイベントにノイズがあるか否かを判断することを含む波形評価の工程を実行するようにさらに構成されており、前記一連のイベントにおける検出間のインタバルを識別する工程は、波形評価の工程において決定されるのにしたがって、ノイズに起因しておらず、かつ、ノイズが支配的でもない検出間のインタバルのみを識別する工程を含む、請求項1に記載のICSD。
- 前記演算回路は、各検出されたイベントが複数の信号振幅サンプルからなるサンプルウィンドウに付随するようにさらに構成されており、各検出されたイベントのサンプルウィンドウには1つの正のピークと1つの負のピークとが含まれ、形態解析はインタバル解析を含む幅広群の解析を含み、インタバル解析では、所定の幅広群の閾値インタバルより短いインタバルによって第1および第2の検出されたイベントが分離されているとき、かつ、次の条件のうちの少なくとも1つ、すなわち、
第1および第2の検出されたイベントは極性が反対であること、および、
第1および第2の検出されたイベントのピークインタバルが所定の閾値より小さいこと、のうちの少なくとも1つが識別されるとき、過検出が識別され、
ピークインタバルは、第1および第2のイベントのうちの先行するイベントの正のピークおよび負のピークの内の後続のピークと、第1および第2のイベントのうちの後続のイベントの正のピークおよび負のピークの内の先行するピークとの間のインタバルとして規定され、
幅広群の解析が満足される場合、第1および第2のイベントのうちの1つは過検出として標識される、請求項1に記載のICSD。 - 前記幅広群の解析が満足される場合、
ICSDに形態テンプレートが存在するとき、第1および第2の検出されたイベントのうち、形態テンプレートに対して低い相関性を示すものを過検出として標識し、
ICSDに形態テンプレートが存在しないとき、第1および第2の検出されたイベントのうち、時間的に後のものを過検出として標識する、請求項3に記載のICSD。 - 前記演算回路は、形態解析がテンプレート形態解析を含むようにさらに構成されており、テンプレート形態解析では、
検出されたイベントは、相関性スコアを生成するために形態テンプレートと比較され、
一連の相関性スコアは、高または低として特徴付けられ、
高−低−高のパターンは、過検出を示すものとして識別され、
高−低−高のパターンが識別される場合、低の相関性スコアを有する検出されたイベントは過検出として識別される、請求項3に記載のICSD。 - 前記演算回路は、形態解析がテンプレート形態解析を含むようにさらに構成されており、テンプレート形態解析では、
検出されたイベントは、相関性スコアを生成するために形態テンプレートと比較され、
一連の相関性スコアは、高または低として特徴付けられ、
高−低−高のパターンは、過検出を示すものとして識別され、
高−低−高のパターンが識別される場合、低の相関性スコアを有する検出されたイベントは過検出として識別される、請求項1に記載のICSD。
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